Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the Clinic Manager on 2 /7/2019 at approximately 12:00 pm, the laboratory failed to ensure the Laboratory Director (LD) signed and approved the current Quality Assurance procedures. Findings include: 1. The procedure for "Quality Assurance for Interpretation of Histopathology slides" was not signed and approved by the LD. 2. The procedure "Epic Workflow Reading and Interpretation of Pathology slides" was not signed and approved by the LD. 3. The clinic manager confirmed that the LD had not signed off on the above two procedures since the last revision. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --